NCT02366117

Brief Summary

The study design is that of a cluster randomised controlled trial The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended. The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions. The selection of the sample was by residential units for people with long-term mental disorders. The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded. The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

February 9, 2015

Last Update Submit

February 11, 2015

Conditions

Keywords

QuircQuality Indiciator in Rehabilitative Care

Outcome Measures

Primary Outcomes (1)

  • Percentage of time spent in any activity during a week by patients

    The percentage of time spent will be measured by the "Time Use Diary" instrument.

    Four months

Study Arms (2)

Training

EXPERIMENTAL

Data collected during the first pahse of the study will be presented and discussed in a specialist focus group, which will work with the study team as advisors and trainers, to decide on the type of training to be developed. This training intervention will be applied to the facilities presenting half the patient sample size.

Behavioral: Training

No Training

NO INTERVENTION

Facilities representing half the sample size will not be trained as in the Experimental Arm and continue their standard of care for these patients.

Interventions

TrainingBEHAVIORAL

Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.

Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mental Health Problems

You may not qualify if:

  • Refusal to enter the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Ciências Médicas

Lisbon, Lisbon District, 1169-056, Portugal

Location

Related Publications (1)

  • Cardoso G, Papoila A, Tome G, Killaspy H, King M, Caldas-de-Almeida JM. A cluster randomised controlled trial of a staff-training intervention in residential units for people with long-term mental illness in Portugal: the PromQual trial. Soc Psychiatry Psychiatr Epidemiol. 2017 Nov;52(11):1435-1445. doi: 10.1007/s00127-017-1416-7. Epub 2017 Jun 30.

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 19, 2015

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations